The Janssen Pharmaceutical Companies of Johnson & Johnson have entered a worldwide collaboration with Theravance Biopharma to develop TD-1473, a first-in-class oral, gastrointestinal (GI) restricted pan-Janus kinase (JAK) inhibitor for the treatment of inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis (UC).  
Theravance will complete a Phase II study in Crohn’s disease and a Phase IIb/III study in UC, planned to start in 2018. Following Phase II data from both studies, Janssen Biotech may elect to enter an exclusive license arrangement for the program and would then assume subsequent development of TD-1473 in Crohn’s disease.

Theravance will continue TD-1473 development in UC through the conclusion of the Phase IIb/III program. If TD-1473 is commercialized, Theravance has the option to co-commercialize in the U.S., and Janssen would have sole commercialization outside the U.S. Theravance will receive an upfront payment and will be eligible to receive additional payments following the completion of Phase II studies.

TD-1473, a potential first-in-class oral, local acting GI restricted pan-JAK inhibitor specifically designed to act directly at the inflammation site in the intestinal wall to limit systemic exposure.

“Adding TD-1473 to the Janssen Immunology portfolio reinforces our commitment to transforming patient outcomes with the potential to offer a first-in-class oral, local acting pan-JAK inhibitor with broad use across GI-related inflammatory disease,” said Scott E. Plevy, M.D., vice president, Disease Area Leader, Inflammatory Bowel Disease, Janssen Research & Development, LLC. “We look forward to advancing this promising, oral, drug candidate through clinical development as we continue to address the significant unmet needs of people living with Crohn’s disease and UC around the world.”